The Effectiveness of Probiotics for the Therapy of Acute Pharyngotonsillitis in Adult Patients

Ziv Hospital

Status and phase: Completed; Phase 3

Conditions: Throat Pain

Treatments: Drug: Placebo; Drug: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT01679366

0054-11-ZIV

Details and patient eligibility

About

The addition of probiotics to the routine therapy of Acute Pharyngotonsillitis in adult patients may shorten the duration, and reduce the severity of the disease.

Full description

Hypothesis The addition of probiotics to the routine therapy of AP in adult patients may shorten the duration, and reduce the severity of the disease.

Study design A prospective, randomized, placebo-controlled, double-blinded study comparing treatment with probiotics to placebo in patients with AP.

The study will be conducted in accordance with the ethical standards of the Helsinki Declaration and will be approved by the Human Experimentation Ethics Committee of the Ziv Medical Center. Signed informed consent will be required from all patients before inclusion.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18 years
• Acute pharyngotonsillitis for which hospitalization for intravenous antibiotic treatment and/or fluids is needed

Exclusion criteria

• Current therapy with systemic prednisone or equivalent at 20 mg/d for more than 10 days prior to inclusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 3 patient groups, including a placebo group

Penicillin G

No Intervention group

Description:

hospitalization of 30 patients given penicilline intraveniously for 72 hours

Placebo

Placebo Comparator group

Description:

30 hospitalized patients will be given placebo with a regular penicillin treatment

Treatment:

Drug: Placebo

Probiotic

Experimental group

Description:

Probiotics will be given to 30 hospitalized patients with regular penicillin treatment

Treatment:

Drug: Probiotics